Live WEBINAR/ Jun 3rd at 12 pm ETD: From Bench to Scale: Scaling Biodegradable mRNA Lipid Nanoparticle for Clinical Success

 https://xtalks.com/webinars/from-bench-to-scale-scaling-biodegradable-mrna-lipid-nanoparticle-for-clinical-success/

This webinar will introduce participants to the challenges and considerations in development and scale-up of mRNA lipid nanoparticles (LNPs) composed of biodegradable lipids. Attendees will learn the role of individual lipid components in formulation design and strategies to maximize impact on potency, tolerability and scalability for commercial success. Subsequently, a case study will be presented highlighting the scale-up of an LNP formulation, including upstream microfluidic mixing optimization and downstream processing via tangential flow filtration (TFF).

Lipid nanoparticles (LNPs) are the leading non-viral delivery system and are being developed for the treatment of a wide range of diseases and genetic conditions. During the preclinical development phase, LNP formulations are optimized for potency and safety based on the target disease indication and route of administration. To support the early stages of development, small-scale LNP batches are often fabricated using microfluidics and downstream processing via dialysis and ultrafiltration. These small-scale unit operations are material sparing, efficient and yield high-quality LNPs.

Upon selection of a lead formulation, a critical next step towards investigational new drug (IND)-enabling studies involves scaling up the LNP fabrication process, including upstream mixing and downstream purification processes. Microfluidic and turbulent mixing options are available for the upstream unit operation, whereas TFF is commonly utilized for downstream purification and product concentration. During scale-up, the LNP critical quality attributes must be maintained, including particle size, PDI and cargo encapsulation efficiency.

Register for the webinar to gain practical insights into the formulation and scale-up of biodegradable lipid nanoparticles for mRNA delivery.